Exact Sciences Launches Cancerguard Test for Early Multi-Cancer Detection

Shots: Exact Sciences has introduced the Cancerguard test for early multi-cancer detection & has partnered with Quest Diagnostics to expand patient access in the US Cancerguard is supported by extensive clinical data, incl. DETECT-A & ASCEND 2 studies in over 20,000 subjects. Additionally, Exact is enrolling ~25,000 participants in the Falcon registry study following the…

ByRidhi RastogiSeptember 10, 2025

NEWS

Pulse Biosciences Receives FDA IDE Approval for nsPFA Cardiac Surgery System to Treat Atrial Fibrillation

Shots: Pulse Biosciences has received the US FDA IDE approval to initiate its NANOCLAMP AF study evaluating nsPFA system in ~136 pts with atrial fibrillation (AF) across 20 sites, incl. 2 outside the US The EU feasibility study of nsPFA Cardiac Clamp began in Aug 2024 with over 40 pts across 3 sites The Netherlands,…

ByRidhi RastogiSeptember 9, 2025

NEWS

ONWARD Medical Receives FDA IDE Approval for ARC-IM System to Treat Blood pressure Instability in Spinal Cord Injury

Shots: ONWARD Medical has received the US FDA IDE approval to initiate its Empower BP study evaluating ARC-IM System for blood pressure instability in spinal cord injury The IDE trial will assess ARC-IM System in pts with C2–T6 spinal cord injuries, injury severities of AIS A-D & blood pressure instability, incl. chronic OH & autonomic…

ByRidhi RastogiAugust 19, 2025

NEWS

Myra Vision Receives FDA Conditional IDE Approval for Calibreye TGT System to Treat Glaucoma

Shots: Myra Vision received the US FDA conditional IDE approval to initiate its ADAPT study evaluating Calibreye Titratable Glaucoma Therapy (TGT) surgical system for glaucoma The IDE trial will evaluate the safety and efficacy of Calibreye TGT surgical system in ~70 refractory glaucoma pts with 12mos. primary effectiveness endpoint Calibreye System allows ophthalmologists to control…

ByRidhi RastogiAugust 13, 2025

NEWS

Dymicron Secures US FDA IDE Approval for Triadyme-C Cervical Disc Study

Shots: Dymicron received the US FDA’s IDE approval to initiate a pivotal trial of Triadyme-C, a cervical artificial disc, to treat symptomatic cervical disc disease (SCDD) across leading US spine centers starting Q4’25 The study will compare the safety and effectiveness of Triadyme-C vs. anterior cervical discectomy and fusion (ACDF). The 1EP of the study…

ByRidhi RastogiJuly 11, 2025

NEWS

Simpson Interventions Receives the US FDA’s 510(k) Clearance for its Shadow Catheter and IDE Approval for its Acolyte Catheter System

Shots: Simpson Interventions reported the grant of IDE by the US FDA to Acolyte Image-Guided Crossing & Re-Entry Catheter System plus 510(k) clearance for its Shadow Catheter Acolyte System intends to enables cardiologists with revascularization of coronary chronic total occlusion (CTO). In Mar 2024, it was designated with the US FDA’s BDD and included…

BySenior EditorJanuary 8, 2025

VIEWPOINTS

Dr. Christopher Piorkowski Shares His Views on the US FDA Approval of TactiFlex Ablation Catheter to Treat Abnormal Heart Rhythm

Shots: Christopher started by highlighting the working of the TactiFlex Ablation Catheter and how it can be used for the treatment of patients with Atrial Fibrillation He also talked about the study design and the key findings from the TactiFlex AF IDE trial. He later gave a comparative view of the TactiFlex catheter vs. conventional…

BySenior EditorSeptember 11, 2023

Exact Sciences Launches Cancerguard Test for Early Multi-Cancer Detection

Pulse Biosciences Receives FDA IDE Approval for nsPFA Cardiac Surgery System to Treat Atrial Fibrillation

ONWARD Medical Receives FDA IDE Approval for ARC-IM System to Treat Blood pressure Instability in Spinal Cord Injury

Myra Vision Receives FDA Conditional IDE Approval for Calibreye TGT System to Treat Glaucoma

Dymicron Secures US FDA IDE Approval for Triadyme-C Cervical Disc Study

Simpson Interventions Receives the US FDA’s 510(k) Clearance for its Shadow Catheter and IDE Approval for its Acolyte Catheter System

Dr. Christopher Piorkowski Shares His Views on the US FDA Approval of TactiFlex Ablation Catheter to Treat Abnormal Heart Rhythm

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